The Use of Steri3X for Prevention of Post-operative Wound Infections in

Status Not yet recruiting

Clinical Trial Summary

Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Clinical Trial Description

Postpartum infection is a major cause of maternal morbidity and prolonged hospitalization, and places a large burden on the healthcare system with an additional cost of $3,700 (Olsen et al., 2010). Surgical site infection (SSI) is one of the most common post-operative complications following cesarean section, with an incidence of 3-15% worldwide (Zuarez-Eaaston et al., 2017). Wound dressings that are applied after closure of a surgical incision may help healing by providing physical support, protection from external contaminants, and by absorbing exudate (Dumville et al., 2016). A new FDA-approved microbicidial liquid adhesive, Steri3X, has been shown to reduce the incidence of pin-tract infection by 100% in a randomized-controlled trial following external fixation in patients undergoing reconstructive surgery for deformity correction (Pema, 2020). Steri3X is reported to be effective against S. aureus (both MSSA and MRSA), Candida albicans, E. coli, P. aeruginosa, and Candida auris, which are common organisms involved in dermatological infections. The most common organisms responsible for cesarean section SSI include enteric gram negative bacilli, enterococci, and group B streptococcus (Gur et al., 2015). The advantage of this polymer following C-sections is unknown, and a larger study is needed to provide a more robust analysis. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05392400
Study type	Interventional
Source	University of Tennessee
Contact	Bethany Erickson, MD
Phone	7012268304
Email	bericks5@uthsc.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	February 7, 2023
Completion date	February 7, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms